Action Points

Explain to interested patients that this study found that larval therapy and hydrogel treatment resulted in similar healing times for leg ulcers with similar costs.

Point out that the researchers said maggot therapy may be considered if the goal of treatment is faster clearance of dead tissue from wounds.

YORK, England, March 20 -- For treating leg ulcers, maggot therapy was as effective as standard therapy with hydrogel, albeit more painful, a randomized trial showed.

Although the larvae cleared the ulcers of dead tissue more quickly (P<0.001), total healing time was not significantly different between the two therapies (P=0.62), Jo Dumville, Ph.D., of the University of York, and colleagues reported online in BMJ.

The two groups of patients did not differ in health-related quality of life or bacterial load either, but pain was significantly greater for patients whose ulcers were debrided by maggots (P<0.001).

"We found no evidence to recommend the routine use of larval therapy on sloughy leg ulcers to speed up healing or reduce bacterial load," the researchers said.

However, they said, "if debridement in itself is a goal of treatment, such as before skin grafting or other surgery, then larval therapy should be considered."

Debridement is a common part of managing leg ulcers and is believed to promote healing, the researchers said.

Some investigators have suggested that maggots would debride wounds faster than conventional therapy, thereby reducing bacteria and healing time. But only one randomized controlled trial had explored the issue, and it included only a small number of patients.

So Dr. Dumville and colleagues undertook VenUS II, a randomized controlled trial conducted at 18 British centers with 267 participants (mean age 74).

All patients had at least one venous or mixed venous and arterial leg ulcer, with dead tissue covering at least a quarter of the wound, and an ankle brachial pressure index of 0.6 or more.

The volunteers were randomized to debridement with bagged larvae (86 patients), loose larvae (94 patients), or hydrogel (87 patients), and followed for a maximum of one year.

Time to complete debridement was significantly shorter in the patients who received larval therapy compared with those who received treatment with hydrogel (median 14 days for loose and 28 days for bagged larvae versus 72 days for hydrogel, P<0.001).

It took a median of 236 days for ulcers debrided by maggots to heal and 245 days for those debrided by hydrogel, a difference that was not statistically significant (P=0.62).

There was no significant difference in the change in overall bacterial load between the two groups or in the proportion of patients who had methicillin-resistant Staphylococcus aureus (MRSA) eradicated (75% with larvae and 50% with hydrogel, P=0.34).

Adverse events occurred at similar rates across groups.

Although patients who received larval therapy had more pain, "pain reported in the 24 hours before removal of the first larvae treatment was considered related to the procedure and was probably transient and did not seem to impact on the health-related quality of life measurements made at three monthly intervals," the researchers said.

In a separate analysis in BMJ, Dr. Dumville and colleagues found that the costs associated with the larval and hydrogel therapies were not significantly different, although they acknowledged that there was much uncertainty in the estimates.

They concluded that "debridement of sloughy or necrotic leg ulcers with larval therapy is likely to produce similar health benefits and have similar costs to treatment with hydrogel."

"It could be argued that healthcare decision-makers should be indifferent when recommending these two therapies . . . or that the decision should be driven by the goal of treatment (for example, if debriding an ulcer rapidly is important when a skin graft is planned)," they said.

Patient preference should be considered beyond that, they said.

The authors acknowledged some limitations of the study, including the lack of information on how many ulcers remained debrided in the long term and on bacterial flora besides MRSA, as well failure to reach the target for the initial study sample size.

The study was funded by the U.K. National Institute for Health Research Health Technology Assessment Program. Zoobiotic supplied and distributed the loose larvae at no cost and Biomonde supplied the bagged larvae at no cost.

The authors reported no conflicts of interest.

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

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